| CTRI Number |
CTRI/2019/12/022542 [Registered on: 27/12/2019] Trial Registered Prospectively |
| Last Modified On: |
26/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Prediction of difficult airway via preoperative LEMON’S airway assessment criteria |
|
Scientific Title of Study
|
Incidence and Prevalence of Difficult Airway by correlating The LEMON’S Assessment score with The Cormack Lehane Grading at the time of laryngoscopy – An Observational study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Prerana Nirav Shah |
| Designation |
Professor (Additional) |
| Affiliation |
Professor (Additional) Affliation GSMC KEMH |
| Address |
Department of Anaesthesiology, GSMC KEMH, Parel
Mumbai
MAHARASHTRA
400012
India
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9869117027 |
| Fax |
|
| Email |
PPS@KEM.EDU |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Natasha Imtiyaz Bengali |
| Designation |
Resident |
| Affiliation |
GSMC KEMH |
| Address |
Department of Anaesthesiology, GSMC KEMH Parel
Mumbai
MAHARASHTRA
400012
India
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9819354194 |
| Fax |
|
| Email |
natashabengali718@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Natasha Imtiyaz Bengali |
| Designation |
Resident |
| Affiliation |
GSMC KEMH |
| Address |
Department of Anaesthesiology, GSMC KEMH Parel
Mumbai
MAHARASHTRA
400012
India
MAHARASHTRA
400012
India |
| Phone |
9819354194 |
| Fax |
|
| Email |
natashabengali718@gmail.com |
|
|
Source of Monetary or Material Support
|
|
Department of Anaesthesiology, 1st floor, GSMC KEMH Mumbai 400012 |
|
|
Primary Sponsor
|
| Name |
GSMC KEMH |
| Address |
Department of Anaesthesiology, 1st Floor, old hospital building, Parel, Mumbai 400012 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Natasha Imtiyaz Bengali |
GSMC KEMH |
Department of Anaesthesiology, GSMC & KEmMH, Parel
Mumbai
MAHARASHTRA
Mumbai
MAHARASHTRA |
9819354194
natashabengali718@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee IEC-II |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1) Participants undergoing all kind of elective surgery requiring endotracheal intubation
2) Patients above 18 years of age |
|
| ExclusionCriteria |
| Details |
1) Patients refusing to participate in the study 2) Patient with an in-situ endotracheal tube 3) Pregnant woman 4) Patients requiring Rapid Sequence Intubation (RSI). 5) Patients having a restricted mouth opening of <2cm or Temperomandibular joint immobility in whom laryngoscope cannot be inserted and hence Cormack Lehane Grading not possible. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the incidence of anticipated difficult airway by using the LEMON airway score method and ï‚· To correlate how LEMON method helps in determining difficult intubation with the Cormack-Lehane grade visualized at the time of laryngoscopy |
day prior to surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| duration of laryngoscopy, ï‚· duration of intubation and ï‚· number of attempts of successful intubation |
On day of Surgery |
|
|
Target Sample Size
|
Total Sample Size="380"
Sample Size from India="380"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
30/12/2019 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The prediction of a difficult airway is still a major concern in anaesthesia. A general limitation in the real life clinical setting is that one cannot have all kinds of alternative airway equipment’s at any given time in any given location. Therefore, it is helpful to know beforehand which type of airway problem is expected in each individual patient and consequently which logistic precautions have to be taken in advance. In this study we shall use LEMON SCORE to evaluate patient’s airway and correlate it with Cormack-Lehane (CL) grade visualized at the time of laryngoscopy. This prospective and observational study will be done in 380 patients of age above 18 years of age posted for elective surgery undergoing general anaesthesia requiring endotracheal intubation. The aim of the study is to find out the diagnostic value of LEMON airway assessment score for prediction of difficult laryngoscopy and intubation. In addition duration of laryngoscopy, duration of intubation and number of attempts shall also be noted. |